MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-04-27 for 3343N 3M? CAVILON? NO STING BARRIER FILM N/A manufactured by 3m Health Care.
[106829626]
The product is applied as a liquid and flammable until dry. The label includes a flammability warning and also instructs readers to the instructions for use which states the following warnings: danger! Highly flammable! Cavilon no sting barrier film is highly flammable until it has completely dried on the skin. Cavilon no sting barrier film should only be applied when no ignition sources or heat producing devices are in use. Avoid using around flames. Use in a well ventilated area. The hospital could not confirm a specific ignition source, 3m is still investigating the potential root cause for this reported event.
Patient Sequence No: 1, Text Type: N, H10
[106829627]
A hospital employee reported 3343n 3m? Cavilon? No sting barrier film was applied to existing skin irritation at a patient's iv site on their arm. The skin allegedly ignited where the product was applied. The fire was quickly extinguished by the staff. The patient allegedly experienced a burn. The hospital could not confirm a specific ignition source.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00044 |
| MDR Report Key | 7470778 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRENDAN CASEY, PH.D. |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374488 |
| Manufacturer G1 | 3M HEALTH CARE LIMITED |
| Manufacturer Street | DERBY ROAD |
| Manufacturer City | LOUGHBOROUGH, LEICESTERSHIRE LE115SF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LE11 5SF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3343N 3M? CAVILON? NO STING BARRIER FILM |
| Generic Name | CAVILON NO STING BARRIER FILM |
| Product Code | KMF |
| Date Received | 2018-04-27 |
| Model Number | N/A |
| Catalog Number | 3343N |
| Lot Number | 2020-07 KA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-27 |